Innovasis, Inc

FDA recalling firm · 7 enforcement events · 7 product records · 2014–2026 · UT

Innovasis, Inc has 7 FDA enforcement events on this register (7 product records) between 2014 and 2026: 7 device; the busiest year was 2014 with 1.

0% of its events are Class I; the most common class is Class II (7). 2 events are listed as ongoing; the recalling firm's address is in UT.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
22 May 2026	Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System	Device	Class II	1	Ongoing
14 Aug 2024	TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain. Users of these products are limited to physicians trained in…	Device	Class II	1	Ongoing
7 Apr 2020	Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervical Plate System is intended for use in anterior cervical fixation.	Device	Class II	1	Terminated
8 Jan 2018	Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine:	Device	Class II	1	Terminated
5 May 2017	Opteryx Variable Rescue Screw, Part #CP2214, UDI: +M711CP22140/$$801716012. Packaged in heat-sealed plastic bag. Product Usage: 4.5mm x 14mm Anterior Cervical Plate System Variable Rescue Screw. The Opteryx¿ Cervical Plate System is intended as a temporary fixation device used for correction and stabilization of…	Device	Class II	1	Terminated
7 Dec 2015	Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set. Intended for use in the non-cervical area of the spine.	Device	Class II	1	Terminated
7 Jul 2014	Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.	Device	Class II	1	Terminated

By type and class

Device7

Class II7

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Innovasis, Inc by year initiated.

Questions and answers

How many FDA recalls has Innovasis, Inc had?

7 enforcement events (7 product records) on this register, 2014–2026: 7 device.

Are any Innovasis, Inc recalls ongoing?

2 events are listed as ongoing in the current openFDA export.

What class are Innovasis, Inc recalls?

7 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.